NCT05247450

Conventional-therapy & FES-therapy In-Veritas Effects Study

Conventional-therapy & FES-therapy In-Veritas Effects Study (C-FIVE Study): Rehabilitation of the Upper Extremity for New Persistent C5 Palsy After Surgical Treatment of Patients With Degenerative Cervical Myelopathy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial will primarily compare the effectiveness of conventional physiotherapy alone with combined conventional physiotherapy and FES-t along with task-specific training in terms of the improvement of the functional and neurological recovery of patients with persistent C5 palsy.

Detailed description

This randomized clinical trial will primarily compare the effectiveness of conventionalphysiotherapy alone with combined conventional physiotherapy and FES-t along with task-specific training in terms of the improvement of the functional and neurological recovery of patients with persistent C5 palsy. Secondarily, this clinical trial will evaluate the effectiveness of combined conventional physiotherapy and FES-t along with task-specific training outcome compared to conventional physiotherapy alone with regards to improved connectivity andexcitability in the ascending and descending pathways as assessed using neurophysiological tests and functional MRI analysis.

Conditions

• C5 Palsy

Interventions

Type	Name	Description
DEVICE	Functional electrical stimulation therapy (FES-t)	Functional electrical stimulation therapy (FES-t) that will use a multichannel device (MyndSearch device).
OTHER	Conventional physiotherapy	Conventional physiotherapy is the current standard of care for rehabilitation of C5 palsy

Timeline

• Start date: 2023-08-16
• Primary completion: 2025-08-30
• Completion: 2025-12-31
• First posted: 2022-02-18
• Last updated: 2024-01-11

Locations

1 site across 1 country: Canada